Application 077652

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	250MG	No	No
002	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	500MG	No	No
003	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077652-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07
A077652-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07
A077652-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077652-001	AB
A077652-002	AB
A077652-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077652-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077652-001	AB	1	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b9dc8bf3-97d9-4d1c-9a68-3ae553acdada	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	5261da15-1b6c-fbe2-e063-6394a90ad85e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	44f31105-5fc9-43d4-e063-6294a90a510f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	264a3f71-f23e-45e3-926a-421bcccf4e3d	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc.	7a12135e-cbad-4fe1-98f7-53c41d1f2a21	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	301ecffc-ecaf-01de-e063-6294a90a61b3	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	cbd5153f-fada-4682-b858-dc3b6e3173cc	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Coupler LLC	2cee61b7-be51-0fe5-e063-6294a90af9e3	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc	067e260c-dc47-4957-a9ff-5a79f17b4ca0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b7a614b0-f604-48e1-9919-21da8f939d93	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Exact identifier application applno (ANDA): 077652 application number: ANDA077652 ndc (product): 65841-691 ndc (product): 65841-692 ndc (product): 65841-693
levofloxacin	LEVOFLOXACIN	Viona Pharmaceuticals Inc	0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652 ndc (product): 72578-100 ndc (product): 72578-098 ndc (product): 72578-099
Levofloxacin	LLEVOFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	19afbe98-484c-c980-e063-6294a90acdc6	2024-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-451	levofloxacin	levofloxacin	Blenheim Pharmacal, Inc.	ANDA	Current
42708-063	levofloxacin	levofloxacin	QPharma Inc	ANDA	Current
50090-2540	levofloxacin	levofloxacin	A-S Medication Solutions	ANDA	Current
50090-2736	levofloxacin	levofloxacin	A-S Medication Solutions	ANDA	Current
58118-1016	levofloxacin	levofloxacin	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1016	levofloxacin	levofloxacin	Clinical Solutions Wholesale, LLC	ANDA	Current
63187-514	levofloxacin	levofloxacin	Proficient Rx LP	ANDA	Current
63187-514	levofloxacin	levofloxacin	Proficient Rx LP	ANDA	Current
63187-514	levofloxacin	levofloxacin	Proficient Rx LP	ANDA	Current
63629-7050	levofloxacin	levofloxacin	Bryant Ranch Prepack	ANDA	Current
63629-7050	levofloxacin	levofloxacin	Bryant Ranch Prepack	ANDA	Current
65841-691	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-691	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-691	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-691	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-691	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-692	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-692	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-692	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-692	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-692	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-693	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-693	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-693	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-693	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
65841-693	levofloxacin	levofloxacin	Cadila Healthcare Limited	ANDA	Current
67296-1119	levofloxacin	levofloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-1119	levofloxacin	levofloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-1123	levofloxacin	levofloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-1123	levofloxacin	levofloxacin	RedPharm Drug, Inc.	ANDA	Current
68382-015	levofloxacin	levofloxacin	Zydus Pharmaceuticals (US	ANDA	Current
68382-015	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-015	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-015	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-016	levofloxacin	levofloxacin	Zydus Pharmaceuticals (US	ANDA	Current
68382-016	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-016	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-016	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-017	levofloxacin	levofloxacin	Zydus Pharmaceuticals (US	ANDA	Current
68382-017	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-017	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-017	levofloxacin	levofloxacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
71335-0428	levofloxacin	levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0428	levofloxacin	levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0428	levofloxacin	levofloxacin	Bryant Ranch Prepack	ANDA	Current
72578-098	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-098	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-099	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-099	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-100	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-100	levofloxacin	levofloxacin	Viona Pharmaceuticals Inc	ANDA	Current